New York Eye and Ear Infirmary of Mount Sinai, New York, New York; Columbia University Irving Medical Center, Department of Ophthalmology, New York, New York.
New York Eye and Ear Infirmary of Mount Sinai, New York, New York.
Ophthalmol Glaucoma. 2021 Jul-Aug;4(4):421-426. doi: 10.1016/j.ogla.2020.12.005. Epub 2020 Dec 16.
The purpose of this study is to evaluate the effectiveness of Ologen collagen matrix (OCM; Aeon Astron Corporation) in the prevention of the postoperative hypertensive phase and on long-term intraocular pressure (IOP) control after Ahmed glaucoma valve (AGV; New World Medical) implantation.
This is a prospective, randomized, controlled study of 26 patients treated at a tertiary care center, with 13 eyes assigned to each treatment arm.
Consecutive patients with refractory glaucoma requiring AGV implantation were enrolled. Refractory glaucoma was defined as IOP >21 mmHg on maximum tolerated glaucoma medications or progressive visual field and optic nerve head changes despite maximal tolerated medical therapy.
In Ologen eyes, a round 12 × 1-mm OCM segment was placed flush over the AGV-FP7 plate immediately before conjunctival closure. Control eyes received conventional AGV surgery without OCM implantation.
The primary outcomes were postoperative IOP and requirement of pressure-lowering medications. On the basis of these measures, the rates of complete and qualified success over the course of follow-up were calculated. Complete success was defined as IOP ≤21 mmHg without antihypertensive medications. Qualified success was defined as IOP ≤21 mmHg with or without medications. Frequency of hypertensive phase was also determined.
Patients receiving Ologen-augmented AGV surgery exhibited significantly lower IOPs compared with control subjects at the 1-, 2-, and 3-month time points (P < 0.04). Maximum mean IOP postoperatively was 25.2 ± 7.4 for control eyes and 16.8 ± 8.9 for Ologen eyes, peaking at month 2 for both groups and stabilizing by month 6. No differences in average number of pressure-lowering medications were detected between groups. There were no statistically significant differences in complete or qualified success rates at 6 and 12 months. The frequency of hypertensive phase was 61.5% in control eyes and 38.5% in OCM-implanted eyes.
Ologen collagen matrix-augmented AGV surgery may provide better IOP control in the intermediate postoperative period and blunt the hypertensive phase compared with AGV implantation alone.
本研究旨在评估 Ologen 胶原基质（OCM；Aeon Astron 公司）在 Ahmed 青光眼引流阀（AGV；New World Medical）植入术后预防高血压期和长期眼压（IOP）控制方面的效果。
这是一项在三级医疗中心进行的前瞻性、随机、对照研究，共有 26 例患者参与，其中每只眼随机分配到治疗组。
连续收治需要接受 AGV 植入的难治性青光眼患者。难治性青光眼定义为最大耐受青光眼药物治疗后 IOP>21mmHg，或尽管最大耐受药物治疗仍有进行性视野和视神经头改变。
在 Ologen 眼中，在结膜闭合前立即将 12×1mm 的 OCM 段平齐放置在 AGV-FP7 板上。对照组接受不植入 OCM 的常规 AGV 手术。
主要观察指标为术后 IOP 和降压药物的需求。根据这些指标，计算出随访过程中完全成功和合格成功的比例。完全成功定义为 IOP≤21mmHg 且无需降压药物。合格成功定义为 IOP≤21mmHg，无论是否使用药物。还确定了高血压期的发生频率。
接受 Ologen 增强 AGV 手术的患者与对照组相比，在 1、2 和 3 个月时的 IOP 明显较低（P<0.04）。对照组术后最大平均 IOP 为 25.2±7.4mmHg，Ologen 组为 16.8±8.9mmHg，两组均在第 2 个月达到峰值，并在第 6 个月稳定。两组间降压药物的平均数量无统计学差异。在 6 个月和 12 个月时，完全成功和合格成功的比例无统计学差异。对照组高血压期的发生率为 61.5%，OCM 植入组为 38.5%。
与单独接受 AGV 植入相比，Ologen 胶原基质增强的 AGV 手术可能在术后中期提供更好的 IOP 控制，并减轻高血压期。
